ID
26293
Description
Study Part: Eligibility Checklist Screening. An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165
Keywords
Versions (1)
- 10/15/17 10/15/17 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 15, 2017
DOI
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License
Creative Commons BY-NC 3.0
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Eligibility Checklist Screening Ropinirole Parkinson Disease 101468/165
Eligibility Checklist Screening
- StudyEvent: ODM
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
comorbidity Mental disorders Hematological Disease
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0004936
- UMLS CUI [1,3]
- C0018939
Description
Laboratory test result abnormal aspartate aminotransferase serum creatinine
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0438215
- UMLS CUI [1,2]
- C0004002
- UMLS CUI [1,3]
- C0201976
Description
Hepatitis B surface antigen positive; Hepatitis C antibody positive; HIV Seropositivity
Data type
boolean
Alias
- UMLS CUI [1]
- C0149709
- UMLS CUI [2]
- C0281863
- UMLS CUI [3]
- C0019699
Description
syncope; orthostatic hypotension; Blood pressure
Data type
boolean
Alias
- UMLS CUI [1]
- C0039070
- UMLS CUI [2]
- C0020651
- UMLS CUI [3]
- C0005823
Description
sleep disorder
Data type
boolean
Alias
- UMLS CUI [1]
- C0851578
Description
blood pressure
Data type
boolean
Alias
- UMLS CUI [1]
- C0005823
Description
L-dopa preparation
Data type
boolean
Alias
- UMLS CUI [1]
- C0023570
Description
concomitant medication dopaminergic agonists
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0178601
Description
concomitant medication CYP1A2
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0207509
Description
adverse event ropinirole
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0244821
Description
adverse event Dopaminergic Agents dyskinesias
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0013036
- UMLS CUI [1,3]
- C0013384
Description
concomitant medication
Data type
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
blood donation; Hemorrhage
Data type
boolean
Alias
- UMLS CUI [1]
- C0005794
- UMLS CUI [2]
- C0019080
Description
substance abuse disorders
Data type
boolean
Alias
- UMLS CUI [1]
- C0038586
Description
Study Subject Participation Status
Data type
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
pregnancy; lactating
Data type
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
Similar models
Eligibility Checklist Screening
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])
C0004936 (UMLS CUI [1,2])
C0018939 (UMLS CUI [1,3])
C0004002 (UMLS CUI [1,2])
C0201976 (UMLS CUI [1,3])
C0281863 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
C0020651 (UMLS CUI [2])
C0005823 (UMLS CUI [3])
C0178601 (UMLS CUI [1,2])
C0207509 (UMLS CUI [1,2])
C0244821 (UMLS CUI [1,2])
C0013036 (UMLS CUI [1,2])
C0013384 (UMLS CUI [1,3])
C0019080 (UMLS CUI [2])
C0006147 (UMLS CUI [2])